On track at CPHI Barcelona - The Track Sponsor interview: USP

In our packed out content sessions at CPHI Barcelona this year we focus on some of the hottest topics coming up in the pharma industry, with each track sponsored by a leading expert in the field. 

Could you please give an overview of the U.S. Pharmacopeia and what your key priorities are as a non-profit organisation? 

USP is the standard-setting organisation for the official pharmacopeia for pharmaceuticals approved for use in the United States. This includes all dosage forms, active pharmaceutical ingredients, and excipients. We also set standards for dietary supplements and conventional food ingredients. We are a global organisation with offices in the United States, South America, Europe, China, South Asia, Asia Pacific, and Africa. Our main goal is to help ensure global public health by setting quality standards for medicines, supplements, and foods. Our priorities are quality, quality, quality! 

USP are sponsoring CPHI Barcelona’s ‘Quality Management Fundamentals’ track – what are some key takeaways from this track? What ARE some of the fundamentals for quality control and management within the pharmaceutical supply chain? 

The term quality has such a broad meaning. We decided to sponsor this track to level set and gain alignment around fundamental concepts, especially as the industry evolves with new technologies and new products. Do traditional approaches, maybe even definitions, apply to medicines produced in biologic systems or do we need to think differently? What happens to the quality paradigm developed in a batch production world as we move to continuous manufacturing, process analytical technology, and advanced manufacturing technology where even the definition of “batch” is flexible and statistical trends become the basis for decisions. This track explores these issues. We also take a broad view of the pharmaceutical supply chain, beyond the bounds of medicine manufacture. We explore the fundamentals such as the need to know you are partnered with the right suppliers, you have a full understanding of the tolerances and capabilities of your production and have clarity of the fitness for purpose of your raw materials and test methods. 

What challenges face the pharmaceutical manufacturing sector concerning quality control and management? 

Beyond the changing production landscape, the financial pressures (whether driven by global economics or government action), and competitive pressures, the pharmaceutical manufacturing sector is still recovering from the effects of the pandemic. Supply chains are still stretched, with some suppliers and even some competitors disappearing, leaving in their wake shortages of raw materials and finished goods in an industry that is not designed for quickly shifting resources or adding capacity due to capital requirements and needed regulatory approvals. What this sometimes means is medicine manufacturers try to accelerate identification and approval of new suppliers of raw materials and raw materials supplies, sometimes pushing production above design. Both can lead to quality issues from not fully understanding the impact of a new supplier on the quality of your product. These situations demand more resources to move quickly, but in a manner that is designed to protect the quality of medicines. 

As an example, poor quality excipients containing diethylene glycol and ethylene glycol are still causing harm despite a long and well publicised history of issues, changes to standards to make clear what testing must be done, new approaches to make the supply chain more transparent, and multiple warnings by regulatory agencies. 

What do you hope to bring to CPHI Barcelona with the Quality Management Fundamentals track? 

We hope this track opens a global dialogue about risks to quality to build a stronger understanding of how those risks are presenting themselves. We view this as a topic that needs ongoing discussion. 

How do events like CPHI Barcelona help to accelerate these track fields in the wider pharmaceutical industry? 

CPHI Barcelona brings together all of the right voices to discuss these kinds of issues. New companies and those new to the industry learn more and add their voice to the dialogue by highlighting their challenges. Well-established companies bring their long and deep experience and perspective and transfer that knowledge. In all, there are few places where you can have access to such a diverse gathering of experts and those thirsty to learn.